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Re: Biobillionair post# 214907

Wednesday, 09/18/2019 11:25:06 AM

Wednesday, September 18, 2019 11:25:06 AM

Post# of 428492
BB, we should be on the look out for a press release soon from AMRN regarding a formal PDUFA delay with explanation. Following are some examples:

Karyopharm Announces FDA Extension of Review Period for Selinexor New Drug Application,

https://investors.karyopharm.com/news-releases/news-release-details/karyopharm-announces-fda-extension-review-period-selinexor-new

Xeris Pharmaceuticals Receives Notification of PDUFA Date Extension for Gvoke™,

https://www.globenewswire.com/news-release/2019/06/06/1865633/0/en/Xeris-Pharmaceuticals-Receives-Notification-of-PDUFA-Date-Extension-for-Gvoke.html

Sage Therapeutics Receives Notification of PDUFA Extension for ZULRESSO™ (brexanolone) Injection,

https://investor.sagerx.com/news-releases/news-release-details/sage-therapeutics-receives-notification-pdufa-extension

Merck's Keytruda faces delay in first-line approval decision,

https://www.biopharmadive.com/news/merck-keytruda-first-line-fda-approval-delay/544964/

In a rare delay for the fast PD-1/L1 crowd, FDA tells Roche to wait on its Tecentriq/Avastin triple for lung cancer,

https://endpts.com/in-a-rare-delay-for-the-fast-pd-1-l1-crowd-fda-tells-roche-to-wait-on-its-tecentriq-avastin-triple-for-lung-cancer/












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